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Senior Director – ExploR&D Regulatory Writing and Capabilities
Eli Lilly and Company. Lead the regulatory and medical writing function within ExploR&D .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory and medical writing, with a strong focus on developing and implementing document standards, workflows, and AI-driven tools. Proven ability to lead cross-functional teams and manage external partnerships while ensuring compliance with regulatory guidelines.
Highest-signal resume keywords
Regulatory WritingClinical Trial ProcessesProject ManagementLeadership in Document DevelopmentAI-Driven Tools Implementation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory AffairsClinical DevelopmentPharmacologyToxicologyGCP RegulationsGLP RegulationsDocument ManagementScientific PublicationsPreclinical DevelopmentAutomation Tools
Soft Skills
Critical ThinkingStrategy DevelopmentDecision-MakingInterpersonal SkillsFlexibility
Tools & Technologies
Document-Management ToolsWord Processing SoftwareSpreadsheetsPresentation SoftwareAI Authoring Tools
Certifications & Qualifications
Advanced Graduate Degree (PharmD, PhD, MD)
Industry Keywords
Pharmaceutical IndustryClinical DevelopmentRegulatory GuidelinesBiotech PartnershipsSOPs
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead the regulatory and medical writing function within ExploR&D
- Oversee preparation and delivery of clinical and regulatory documents
- Develop IT tools supporting document-writing needs for ExploR&D and partners
- Manage business processes, vendors, systems, system implementation, and emerging technology implementation
- Provide strategic, tactical, technical, and operational direction across the ExploR&D portfolio
- Lead writing deliverables and strategies
- Collaborate with internal and external multidisciplinary stakeholders
- Coordinate content across complex preclinical, clinical, regulatory, and scientific documents
- Lead cross-functional teams to deliver writing outputs on time
- Manage and track workload and escalate resource-capacity issues
- Plan, write, edit, review, and strategically coordinate regulatory documents, development strategies, and scientific publications
- Oversee quality review and document finalization
- Provide expertise on databases and document-management tools
- Represent ExploR&D in assigned projects and interact with biotech partners
- Build and manage relationships with biotech partners and vendors
- Contribute to collaboration opportunity identification, prioritization, and assessment
- Maintain knowledge of regulatory and publication guidelines and share best practices across Lilly
- Build AI writing capabilities and implement systems and tools such as AI authoring, automation, and document-management tools
- Allocate medical-writing resources to incoming projects
- Implement document standards, workflows, priorities, process improvements, SOPs, and templates
- Coach, mentor, train, recruit, develop, and retain medical-writing staff as assigned
- Champion quality, safety, inclusion, innovation, and judgment-based decision-making
Requirements
What you’ll need- Advanced graduate degree (PharmD, PhD, MD) in a health-related or scientific field
- At least 7 years’ experience in the pharmaceutical industry in two or more of: preclinical development (PK/PD, pharmacology, toxicology), clinical development, CMC, regulatory affairs, regulatory writing
- At least 3 years’ experience writing regulatory, clinical trial documents, and/or scientific publications
- Mastery of written English
- Experience in clinical trial processes and/or regulatory activities
- Deep understanding of investigational product requirements, especially GCP and GLP regulations
- Leadership in managing document development for various document types/indications
- Experience managing external partnerships/vendor relationships
- Critical thinking, strategy development, and decision-making skills
- Ability to influence strategies and deliver results in complex or ambiguous environments
- Project management and time management skills
- Leadership and team management skills
- Strong interpersonal skills and flexibility across varying environments and customer groups
- High-level end-user computer skills, including word processing, tables and graphics, spreadsheets, presentations, and templates
- Experience using, developing, or implementing automation tools and software solutions, including AI-driven tools
- Ability to work well across cultures and time zones
- Relocation is not provided
- Writing exercise may be required; writing samples may be requested
Benefits
Comp & perks- Flexible hybrid working options
- Healthcare benefits
- Pension plan/pension benefits
- Life assurance and life insurance/death benefits
- Subsidised canteen
- Onsite gym and fitness benefits
- Travel subsidies
- On-site parking
- Inhouse People Development services
- Educational Assistance
- ‘Live Your BEST Life’ wellbeing initiatives
- Employee assistance program
- Employee clubs and activities
- Vacation benefits
- Flexible benefits
- Certain time off and leave of absence benefits
- Company bonus eligibility depending on company and individual performance